Abstract
1. Cochrane Database Syst Rev. 2019 Mar 26;3:CD009261. doi:
10.1002/14651858.CD009261.pub4.
Negative pressure wound therapy for surgical wounds healing by primary closure.
Webster J(1), Liu Z, Norman G, Dumville JC, Chiverton L, Scuffham P, Stankiewicz
M, Chaboyer WP.
Author information:
(1)National Centre of Research Excellence in Nursing, Centre for Health Practice
Innovation, Menzies Health Institute Queensland, Griffith University, 170 Kessels
Road, Brisbane, Queensland, Australia, 4111.
Update of
Cochrane Database Syst Rev. 2014 Oct 07;(10):CD009261.
BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are
broad and include prophylaxis for surgical site infections (SSIs). While existing
evidence for the effectiveness of NPWT remains uncertain, new trials necessitated
an updated review of the evidence for the effects of NPWT on postoperative wounds
healing by primary closure.
OBJECTIVES: To assess the effects of negative pressure wound therapy for
preventing surgical site infection in wounds healing through primary closure.
SEARCH METHODS: We searched the Cochrane Wounds Specialised Register, CENTRAL,
Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase,
and EBSCO CINAHL Plus in February 2018. We also searched clinical trials
registries for ongoing and unpublished studies, and checked reference lists of
relevant included studies as well as reviews, meta-analyses, and health
technology reports to identify additional studies. There were no restrictions on
language, publication date, or setting.
SELECTION CRITERIA: We included trials if they allocated participants to
treatment randomly and compared NPWT with any other type of wound dressing, or
compared one type of NPWT with another type of NPWT.
DATA COLLECTION AND ANALYSIS: Four review authors independently assessed trials
using predetermined inclusion criteria. We carried out data extraction, 'Risk of
bias' assessment using the Cochrane 'Risk of bias' tool, and quality assessment
according to GRADE methodology.
MAIN RESULTS: In this second update we added 25 intervention trials, resulting in
a total of 30 intervention trials (2957 participants), and two economic studies
nested in trials. Surgeries included abdominal and colorectal (n = 5); caesarean
section (n = 5); knee or hip arthroplasties (n = 5); groin surgery (n = 5);
fractures (n = 5); laparotomy (n = 1); vascular surgery (n = 1); sternotomy (n =
1); breast reduction mammoplasty (n = 1); and mixed (n = 1). In three key domains
four studies were at low risk of bias; six studies were at high risk of bias; and
20 studies were at unclear risk of bias. We judged the evidence to be of low or
very low certainty for all outcomes, downgrading the level of the evidence on the
basis of risk of bias and imprecision.Primary outcomesThree studies reported
mortality (416 participants; follow-up 30 to 90 days or unspecified). It is
uncertain whether NPWT has an impact on risk of death compared with standard
dressings (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.25 to 1.56; very
low-certainty evidence, downgraded once for serious risk of bias and twice for
very serious imprecision).Twenty-five studies reported on SSI. The evidence from
23 studies (2533 participants; 2547 wounds; follow-up 30 days to 12 months or
unspecified) showed that NPWT may reduce the rate of SSIs (RR 0.67, 95% CI 0.53
to 0.85; low-certainty evidence, downgraded twice for very serious risk of
bias).Fourteen studies reported dehiscence. We combined results from 12 studies
(1507 wounds; 1475 participants; follow-up 30 days to an average of 113 days or
unspecified) that compared NPWT with standard dressings. It is uncertain whether
NPWT reduces the risk of wound dehiscence compared with standard dressings (RR
0.80, 95% CI 0.55 to 1.18; very low-certainty evidence, downgraded twice for very
serious risk of bias and once for serious imprecision).Secondary outcomesWe are
uncertain whether NPWT increases or decreases reoperation rates when compared
with a standard dressing (RR 1.09, 95% CI 0.73 to 1.63; 6 trials; 1021
participants; very low-certainty evidence, downgraded for very serious risk of
bias and serious imprecision) or if there is any clinical benefit associated with
NPWT for reducing wound-related readmission to hospital within 30 days (RR 0.86,
95% CI 0.47 to 1.57; 7 studies; 1271 participants; very low-certainty evidence,
downgraded for very serious risk of bias and serious imprecision). It is also
uncertain whether NPWT reduces incidence of seroma compared with standard
dressings (RR 0.67, 95% CI 0.45 to 1.00; 6 studies; 568 participants; very
low-certainty evidence, downgraded twice for very serious risk of bias and once
for serious imprecision). It is uncertain if NPWT reduces or increases the risk
of haematoma when compared with a standard dressing (RR 1.05, 95% CI 0.32 to
3.42; 6 trials; 831 participants; very low-certainty evidence, downgraded twice
for very serious risk of bias and twice for very serious imprecision. It is
uncertain if there is a higher risk of developing blisters when NPWT is compared
with a standard dressing (RR 6.64, 95% CI 3.16 to 13.95; 6 studies; 597
participants; very low-certainty evidence, downgraded twice for very serious risk
of bias and twice for very serious imprecision).Quality of life was not reported
separately by group but was used in two economic evaluations to calculate
quality-adjusted life years (QALYs). There was no clear difference in incremental
QALYs for NPWT relative to standard dressing when results from the two trials
were combined (mean difference 0.00, 95% CI -0.00 to 0.00; moderate-certainty
evidence).One trial concluded that NPWT may be more cost-effective than standard
care, estimating an incremental cost-effectiveness ratio (ICER) value of GBP
20.65 per QALY gained. A second cost-effectiveness study estimated that when
compared with standard dressings NPWT was cost saving and improved QALYs. We
rated the overall quality of the reports as very good; we did not grade the
evidence beyond this as it was based on modelling assumptions.
AUTHORS' CONCLUSIONS: Despite the addition of 25 trials, results are consistent
with our earlier review, with the evidence judged to be of low or very low
certainty for all outcomes. Consequently, uncertainty remains about whether NPWT
compared with a standard dressing reduces or increases the incidence of important
outcomes such as mortality, dehiscence, seroma, or if it increases costs. Given
the cost and widespread use of NPWT for SSI prophylaxis, there is an urgent need
for larger, well-designed and well-conducted trials to evaluate the effects of
newer NPWT products designed for use on clean, closed surgical incisions. Such
trials should initially focus on wounds that may be difficult to heal, such as
sternal wounds or incisions on obese patients.
DOI: 10.1002/14651858.CD009261.pub4
PMCID: PMC6434581
PMID: 30912582 [Indexed for MEDLINE]